An observational study in Preeclampsia (PE), Fetal Growth Restriction and Congenital Abnormalities, sponsored by Institute of Health Information and Statistics of the Czech Republic. Recruiting at 3 sites in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Institute of Health Information and Statistics of the Czech Republic · Observational
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical syndromes (preeclampsia, fetal growth restriction, preterm labor and intrauterine fetal demise "IUFD") and structural congenital defects (morphological and chromosomal).
The primary objective of the project is to create a unified methodology for performing and evaluating the combined first trimester screening in connection with the National Health Information System (hereinafter referred to as "NHIS"), which will enable recording, providing analysis and linking recorded clinical parameters with data in the NHIS. The pilot project will also provide data for modeling appropriate mechanisms for reimbursement from public health insurance.
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The global goal of the project is to develop and implement an appropriate care system for pregnant women, specifically by unifying (standardizing) the process of assessing the fetal anomaly scan and the risk of preeclampsia. This examination in first trimester of pregnancy is not routinely covered by public health insurance and is therefore not available to all women. By standardizing and unifying the screening process, the quality and accessibility of care will be improved for all population groups. This will lead to better health outcomes for the population, including socially excluded groups.
The methodology will be tested on a sample of 2000 women in the first trimester of pregnancy.
The combined firts trimester screening will include collecting the required parameters maternal, ultrasound, biochemical and biophysical. The Fetal Medicine Foundation (FMF) certified software will be used to determine them. FMF certified software will be used to calculate/assess the individual risk of developing pre-eclampsia, fetal growth restriction and the occurrence of fetal chromosomal aneuploidies (trisomies of chromosomes 21, 18 and 13) based on the input parameters.
The project is supported by the European Social Fund Plus (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0003855.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Institute of Health Information and Statistics of the Czech Republic is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women matching all inclusion criteria \& GDPR.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A participant in the project must have signed the Consent to Participate in the Project and the Consent to the Processing of Personal Data.
Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13)
Time frame: From June 2025 to October 2026
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Oct 2026, 16 months after the start.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 16 months is below that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Institute of Health Information and Statistics of the Czech Republic